Events

Safety Alert for CATETER FOR BLOOD PRESSURE MONITORING. Model: C-PMS-300-RA; C-PMS-250; C-PMS-400-RA; C-PMS-400-FA; C-PMS-250-RA, registration 10212990205; risk class II. Lots / Series: 5810917; 5824548, 5824547; 5,810,905; NS6014457; NS6047399; NS6047398; NS6047397; NS6047396; NS6045805; NS6047442; NS6047440; NS6014456; 6067782; NS6063331; NS6063328; NS6108226

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by E. Tamussino & CIA.; Cook Incorporated.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here

Type of Event
Safety alert
Event ID
1817
Date
2016-02-12
Event Country
Brazil
Event Source
ANVISA
Event Source URL
http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
Notes / Alerts

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data

The recall was performed because it could cause potential serious adverse events.
Reason
There may be separation of the catheter tip, which may lead to loss of device function and obstruction of blood flow to terminal organs.
Action
Gathering and destruction. Action code T10071-36 and T10071-37. The manufacturer directs not to use the product and to communicate the company as soon as possible so that the necessary measures are taken.

Device

CATETER FOR BLOOD PRESSURE MONITORING. Model: C-PMS-300-RA; C-PMS-250; C-PMS-400-RA; C-PMS-400-FA...

Model / Serial
Manufacturer
E. Tamussino & CIA.; Cook Incorporated

Manufacturer

E. Tamussino & CIA.; Cook Incorporated

Source
ANVSANVISA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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